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Trial record 64 of 732 for:    Area Under Curve AND Bioavailability

A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00946842
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Tibotec BVBA

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 27, 2009
Last Update Posted Date March 19, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
  • Time to Reach the Maximum Plasma Concentration of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Maximum Plasma Concentration of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Area Under Curve From Time of Administration up to 72 Hours Post Dosing of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
the relative bioavailability of TMC207 after single oral dose administration of the Phase II clinical trial tablet formulation and of a newly developed tablet formulation, under fed and fasted conditions. [ Time Frame: Day 1 (9 time points) and Day 2, 3, 4, 6, 8, 10, 12, 15, 22 and 29 (1 time point per day). ]
Change History Complete list of historical versions of study NCT00946842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
  • Time to Reach the Maximum Plasma Concentration of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Maximum Plasma Concentration of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Area Under Curve From Time of Administration up to 72 Hours Post Dosing of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Area Under Curve From Time of Administration up to the Last Time Point With a Measurable Concentration Post Dosing of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Area Under Curve Extrapolated to Infinity of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Elimination Rate Constant of a Sequential Elimination Phase of the Plasma Concentration-Time Curve of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Elimination Half-Life of M2 Metabolite of TMC207 [ Time Frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration ]
  • Number of Participants With Adverse Events [ Time Frame: Up to 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
  • Pharmacokinetics of M2 after single oral dose of TMC207 as Phase II clinical trial tablet formulation and as newly developed tablet formulation, under fed and fasted conditions [ Time Frame: Day 1 (9 time points) and Day 2, 3, 4, 6, 8, 10, 12, 15, 22 and 29 (1 time point per day). ]
  • Effect of food on the relative bioavailability of TMC207 after single oral dose of each tablet formulation [ Time Frame: Day 1 (9 time points) and Day 2, 3, 4, 6, 8, 10, 12, 15, 22 and 29 (1 time point per day). ]
  • Effect of particle size of active ingredient (TMC207) on bioavailability of TMC207 [ Time Frame: Day 1 (9 time points) and Day 2, 3, 4, 6, 8, 10, 12, 15, 22 and 29 (1 time point per day). ]
  • Evaluation of short-term safety and tolerability of single oral dose of TMC207 [ Time Frame: Day 1, 2, 15 and 29. First Follow-up Day (7 days after last PK sample) and second Follow-up Day (30-35 days after last PK sample) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
Official Title  ICMJE A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions
Brief Summary The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medication or other substance) of TMC207 after single-dose oral administration of the Phase II clinical study tablet formulation, and a newly developed tablet formulations, under fed (with food) and fasted (without food) conditions.
Detailed Description This is a 2-panel (2 groups), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 3- way crossover (method used to switch participants from one treatment arm to another in a clinical study) study. The study consists of 3 phases including, the screening phase (less than or equal to 21 days before administration of study medication), treatment phase (84 days), and the follow-up phase (up to 30 to 35 days after the last blood sample in the last treatment session is collected). Approximately 24 healthy participants will be allocated to one of two panels: Panel A (participants will receive study medication under fed condition); and Panel B (participants will receive study medication under fasted condition). Participants in Panel A will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences ABC, ACB, BAC, BCA, CBA, and CAB) to receive the following 3 formulations of TMC207 with food: Treatments A: the Phase II tablet formulation; Treatment B: newly developed tablet formulation with fine particle size distribution; and Treatment C: newly developed tablet formulation with coarse particle size distribution. Participants in Panel B will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences DEF, DFE, EDF, EFD, FDE, and FED) to receive the following 3 formulations of TMC207 without food: Treatments D: the Phase II tablet formulation; Treatment E: newly developed tablet formulation with fine particle size distribution; and Treatment F: newly developed tablet formulation with coarse particle size distribution. Subsequent treatments will be separated by a period of 4 weeks. The total duration of the study for each participant will be approximately 20 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, electrocardiogram, physical examination, and alcohol urine medicine screen which will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Treatment A
    Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
  • Drug: Treatment B
    Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
  • Drug: Treatment C
    Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
  • Drug: Treatment D
    Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
  • Drug: Treatment E
    Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
  • Drug: Treatment F
    Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58
Study Arms  ICMJE
  • Experimental: Panel A: Treatment Sequence ABC
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence ABC with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel A: Treatment Sequence ACB
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence ACB with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel A: Treatment Sequence BAC
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence BAC with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel A: Treatment Sequence BCA
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence BCA with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel A: Treatment Sequence CBA
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence CBA with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel A: Treatment Sequence CAB
    Participants will receive the 3 treatments (Treatment A,B and C) in sequence CAB with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Panel B: Treatment Sequence DEF
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence DEF with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
  • Experimental: Panel B: Treatment Sequence DFE
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence DFE with food and subsequent treatments will be separated by 4 weeks..
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
  • Experimental: Panel B: Treatment Sequence EDF
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence EDF with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
  • Experimental: Panel B: Treatment Sequence EFD
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence EFD with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
  • Experimental: Panel B: Treatment Sequence FDE
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence FDE with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
  • Experimental: Panel B: Treatment Sequence FED
    Participants will receive the 3 treatments (Treatment D,E and F) in sequence FED with food and subsequent treatments will be separated by 4 weeks.
    Interventions:
    • Drug: Treatment D
    • Drug: Treatment E
    • Drug: Treatment F
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2010)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2009)
24
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-smoker or smokers with no more than 10 cigarettes or 2 cigars or 2 pipes per day for at least 3 months prior selection
  • Normal weight as defined by a body mass index (weight in kilograms divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
  • Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality

Exclusion Criteria:

  • Positive tests for Human Immunodeficiency Virus 1 (HIV type 1) or HIV 2; hepatitis A, hepatitis B, or hepatitis C infection; and urine drug tests at screening
  • Female with no childbearing potential
  • History or current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
  • Relevant medical history or presence of systemic disease (gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, infectious disease), or significant skin disease
  • History or presence of clinically significant electrocardiogram at screening
  • Abnormal laboratory values at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00946842
Other Study ID Numbers  ICMJE CR007504
TMC207-TIDP13-C111 ( Other Identifier: Tibotec-Virco Virology BVBA )
TMC207-C111 ( Other Identifier: Tibotec-Virco Virology BVBA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tibotec BVBA
Study Sponsor  ICMJE Tibotec BVBA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tibotec-Virco Virology BVBA Clinical Trial Tibotec BVBA
PRS Account Tibotec BVBA
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP